Registration Dossier

Administrative data

Description of key information

Eye irritation: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no study available

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline test with GLP
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Two male and one female rabbits(weight range 2.5-3.0kg)were used. They were housed individually in aluminium cages with grid floors beneath which were peat moss filled trays. They were fed on Special Diet Services Rabbit Diet of satisfactory analysis and allowed food and water ad libitum. A 12 h light/dark cycle was in operation. Mean environmental maximum and minimum temperatures were 19℃ and 16℃ and mean relative humidity was 54%. The animals were allowed an acclimatisation period of 63 days before test commencement.
Vehicle:
not specified
Controls:
other: the other eye remained untreated to serve as a control
Amount / concentration applied:
in a single burst
Duration of treatment / exposure:
1 second
Observation period (in vivo):
at 1, 24, 48 and 72 h after instillation
Number of animals or in vitro replicates:
two males and one female
Details on study design:
The rabbit was held firmly but gently and the right eye was held open. The test material was then administered in a single burst of about 1 s duration from a distance of 10 cm directly in front of the eye. The lids were then gently held together for 1 or 2s. The other eye remained untreated to serve as a control. The eyes were examined for irritation, using standard illumination, at 1,24, 48 and 72h ater instillation, using the scoring system as OECD 405.
Irritation parameter:
other: cornea, iris, conjunctivae: redness, chemosis, discharge
Basis:
other: all animals
Time point:
other: 1, 24, 48 and 72h
Score:
0

See data reported in the field "Attached background material".

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
It can be concluded that the test substance is non-irritant to rabbit eyes.
Executive summary:

Two male and one female rabbits were used to conduct this acute eye irritation test. The test material was administered in a single burst of about 1 second duration .The eyes were examined for irritation. The reaction scores for cornea, iris, and conjunctivae in this test are 0. No corneal, iridial or conjunctival responses were noted. Therefore, it can be concluded that the test substance shall not be classified according to CLP(Regulation EC No.1272/2008).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Though the substance is a gas, direct eye irritation data is available, which is a well organized report of guideline testing with GLP. In this study, the test material was administered in a single burst of about 1 second duration. Two male and one female rabbits were used to conduct this acute eye irritation test, which failed to reveal the eye irritation of test substance. No corneal, iridial or conjunctival responses were observed at all animals. Therefore, it can be concluded that the test substance will not be classified according to CLP(Regulation EC No.1272/2008).


Justification for selection of skin irritation / corrosion endpoint:
In accordance with column 2 of Annex VIII - Specific rules for daptation to standard requirements, the skin irritation/corrosion studies (required in section 8.1 and 8.1.1 Annex VII and VIII) do not need to be conducted as the test substance is a flammable gas at the room temperature. In accordance with Annex XI section 1, point 2 of REACH Regulation (EC) No. 1907/2006, the skin irritation/corrosion studies are not technically possible due to technical limitations of the test methods.

Justification for selection of eye irritation endpoint:
guideline test with GLP

Justification for classification or non-classification

According to CLP regulation (Regulation EC No. 1272/2008), it is conclusive but not sufficient for classification on eye irritation.